Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 716 of 1191

FDA device recalls, page 716 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1252-2014	Class II	Natural-Knee II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB...	Zimmer GmbH	HRY	2014-02-25
Z-1251-2014	Class II	Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB...	Zimmer GmbH	HRY	2014-02-25
Z-1250-2014	Class II	MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB...	Zimmer GmbH	KRO	2014-02-25
Z-1249-2014	Class II	Natural-Knee N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1	Zimmer GmbH	JWH	2014-02-25
Z-1248-2014	Class II	Gender Solutions" Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1...	Zimmer GmbH	JWH	2014-02-25
Z-2045-2016	Class II	Myriad handpiece Tissue morcellator	Nico Corporation	GEY	2014-02-24
Z-1513-2014	Class II	ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue...	Brainlab, Inc.	IYE	2014-02-24
Z-1314-2014	Class II	AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet...	Allesee Orthodontic Appliances, Inc.	DYJ	2014-02-24
Z-1208-2014	Class II	REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin)...	Depuy Orthopaedics Inc.	JWH	2014-02-24
Z-1207-2014	Class II	REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin)...	Depuy Orthopaedics Inc.	JWH	2014-02-24
Z-1206-2014	Class II	REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin)...	Depuy Orthopaedics Inc.	KRO	2014-02-24
Z-1205-2014	Class II	REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin)...	Depuy Orthopaedics Inc.	KRO	2014-02-24
Z-1204-2014	Class II	REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin)...	Depuy Orthopaedics Inc.	KRO	2014-02-24
Z-1203-2014	Class II	REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin)...	Depuy Orthopaedics Inc.	KRO	2014-02-24
Z-1210-2014	Class II	DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb...	DeRoyal Industries, Inc.	FMQ	2014-02-21
Z-1234-2014	Class II	MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07...	Medical Information Technology, Inc.	JQP	2014-02-21
Z-1648-2014	Class II	VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human...	Ortho-Clinical Diagnostics, Inc.	KLI	2014-02-20
Z-1839-2014	Class II	Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16...	ConMed Corporation	GEI	2014-02-20
Z-1176-2014	Class II	PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No...	Biosense Webster Inc	MTD	2014-02-20
Z-1329-2014	Class II	Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson &...	Ethicon, Inc	FTM	2014-02-19
Z-1196-2014	Class II	Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF...	Gyrus ACMI, Inc.	KNH	2014-02-19
Z-1149-2014	Class III	Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100...	Medefil, Inc.	NZW	2014-02-19
Z-1212-2014	Class I	FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by...	Abbott Medical	NBW	2014-02-19
Z-1211-2014	Class I	FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at...	Abbott Medical	NBW	2014-02-19
Z-1512-2014	Class I	GemStar Docking Station, used with GemStar infusion pump, in combination with other...	Abbott Medical	FRN	2014-02-18
Z-1270-2014	Class III	Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in...	Lin-Zhi International Inc	DJG	2014-02-18
Z-1553-2014	Class II	ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog #...	Siemens Healthcare Diagnostics Inc.	JJE	2014-02-18
Z-1246-2014	Class II	Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The...	Remel Inc	JTN	2014-02-18
Z-1118-2014	Class II	Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M...	Philips North America LLC	MKJ	2014-02-18
Z-1108-2014	Class II	M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use...	Philips North America LLC	MKJ	2014-02-18
Z-1155-2014	Class II	Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A...	Philips North America LLC	MKJ	2014-02-18
Z-1194-2014	Class II	Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter...	Philips North America LLC	MKJ	2014-02-18
Z-1120-2014	Class II	HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The...	Philips North America LLC	MKJ	2014-02-18
Z-1090-2014	Class II	HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A...	Philips North America LLC	MKJ	2014-02-18
Z-1310-2014	Class III	TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives...	Technidata	JQP	2014-02-17
Z-1197-2014	Class II	XiO RPT System The XiO RTP System is used to create treatment plans for any cancer...	Elekta Limited	MUJ	2014-02-17
Z-1122-2014	Class II	Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric...	WalkMed Technologies, LLC	FRN	2014-02-17
Z-0102-2018	Class II	ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the...	Zimmer GmbH	HAW	2014-02-14
Z-1273-2014	Class II	Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and...	GE Healthcare	DQK	2014-02-14
Z-1245-2014	Class II	GE Healthcare Optima CT580/Discovery CT590RT scanners running software version...	GE Healthcare	JAK	2014-02-14
Z-1481-2014	Class II	RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software...	RaySearch Laboratories AB (publ)	MUJ	2014-02-14
Z-1173-2014	Class II	Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software...	Horiba Instruments Incorporated	JQP	2014-02-14
Z-1109-2014	Class II	Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The...	Philips North America LLC	MKJ	2014-02-14
Z-1505-2014	Class II	MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals...	Siemens Medical Solutions USA, Inc.	KPR	2014-02-13
Z-1172-2014	Class II	VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test...	Accumetrics, Inc.	JOZ	2014-02-13
Z-1147-2014	Class II	GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or...	GE Healthcare	MHX	2014-02-13
Z-3108-2017	Class II	On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the...	Artivion, Inc.	NPT	2014-02-12
Z-1672-2014	Class II	ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic...	Abbott Medical	JJX	2014-02-12
Z-1671-2014	Class II	ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A...	Abbott Medical	JIT	2014-02-12
Z-1045-2014	Class II	CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No...	Biosense Webster Inc	DQK	2014-02-12